Draft guidance from the Food and Drug Administration is seeking to clarify when medical device manufacturers need the agency’s approval to make changes to their products, potentially replacing guidance that had remained unchanged since 1997.

The National Institutes of Health (NIH) has permanently closed its facility which manufactured investigational drugs a year after “a series of deficiencies” were found in the unit by Food and Drug Administration (FDA) inspectors.The National Institutes of Health (NIH) has permanently closed its facility which manufactured investigational drugs a year after “a series of deficiencies” were found in the unit by Food and Drug Administration inspectors.

The California Medical Association (CMA) is opposing a bill which would allow certified nurse-midwives to practice without physician supervision, but not because of the main goal of the legislation, according to Kaiser Health News.

The fight against Zika continued to pick up steam this week after reports of 15 local transmissions in Miami. 

A September 24 deadline set by the Food and Drug Administration is looming for Class II medical devices, such as condoms or wheelchairs, to be outfitted with unique device identifier (UDI) barcodes, but in a survey of device makers, only a few said their companies were currently compliant with the standard.

Recently, the Association of Medical Directors of Information Systems (AMDIS) held their annual awards to recognize leaders in healthcare IT. Among those recipients was Peter Basch, MD, MACP, Senior Director for IT Quality and Safety, Research and National Health IT Policy at MedStar Health.

In an effort to fight the rise in opioid abuse, 29 U.S. Senators are asking CMS to change Medicaid rules to allow substance treatment facilities with more than 16 beds to be reimbursed when they treat Medicaid beneficiaries over the age of 22.

Exposure to racist or discriminatory behaviors over a lifetime can be harmful to overall mental and physical health, according to a new study in the American Journal of Public Health. Such health detriments are disproportionately heaped upon ethnic and racial minorities (especially people of color in Western countries), because they are more likely to be the subjects of such behaviors.